ZONISAMIDE | A077625 | ZYDUS LIFESCIENCES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Newcastle Bioscience LLC FDA-2023-P-4286 · 7 docket documents Newcastle Bioscience LLC filed this citizen petition on October 1, 2023 requesting that the FDA declare Zonisamide Tablets in strengths of 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg suitable for submission as an abbreviated new drug application (ANDA), based on the reference listed drug Zonegr | Suitability | 2023-10-03 | Denied | Newcastle Bioscience LLC |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-0131 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare Zonisamide Orally Disintegrating Tablets in strengths of 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg suitable for submission as an ANDA, representing a change in dosage form from | Other | 2018-01-11 | Denied | Lachman Consultant Services, Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-0130 · 7 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Zonisamide Tablets in strengths of 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg suitable for submission as an abbreviated new drug application, representing a change in dosage form from ca | Other | 2018-01-09 | Denied | Lachman Consultant Services, Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-0098 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Zonisamide Capsules USP in 150 mg, 200 mg, and 300 mg strengths suitable for submission as an ANDA, with Zonegran | Other | 2018-01-09 | Granted | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1078
per ea
Lowest NADAC/Unit
$0.0597
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 72578004201ZONISAMIDE 100 MG CAPSULE | $0.1078 | EA | Generic | — | 2026-06-17 |
| 72578004205ZONISAMIDE 100 MG CAPSULE | $0.1078 | EA | Generic | — | 2026-06-17 |
| 72578004101ZONISAMIDE 50 MG CAPSULE | $0.0950 | EA | Generic | — | 2026-06-17 |
| 72578004001ZONISAMIDE 25 MG CAPSULE | $0.0597 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.